AccessGUDID - DEVICE: BE SMART GET PREPARED (00020424050023)

GUDID

Device Identifier (DI) Information

Brand Name: BE SMART GET PREPARED
Version or Model: 10HDW05002; 10HDW05002HARBOR
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TOTAL RESOURCES INTERNATIONAL INC.

Primary DI Number: 00020424050023
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790160535 *Terms of Use

Device Description: OSHA / ANSI First Aid Kit – 101 pcs - (1) Silvex Wound Gel 0.18 oz [5 g]; (12) Alcohol Prep Pads; (12) Antiseptic Wipes; (6) Antibiotic Ointments 0.03 oz [0.90 g]; (6) Burn Cream 0.03 oz [0.90 g]; (1) Instant Cold Compress 5 in x 6 in [12.70 cm x 15.24 cm]; (25) Sheer Bandages 3/4 x 3 in [1.91 cm x 7.62 cm]; (16) Sheer Bandages 1 in x 3 in [2.54 cm x 7.62 cm]; (10) Sterile Gauze Pads 4 in x 4 in/4 ply [10.16 cm x 10.16 cm]; (4) Sterile Gauze Pads 2 in x 2 in/4 ply [5.08 cm x 5.08 cm]; (1) Triangular Bandage w/ Safety Pins 40 in (1 yd 4 in) x 40 in (1 yd 4 in) x 56 in (1 yd 1 ft 8 in) [1.02 m x 1.02 m x 1.42 m]; (1) Sterile Trauma Pad 5 in x 9 in [12.70 cm x 22.86 cm]; (4) Examination Gloves 2 pairs; (1) Paper Tape 1/2 in x 180 in (5 yd) [1.27 cm x 4.57 m]; (1) First Aid Guide

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44039	First aid kit, medicated	A convenient collection of equipment, materials and pharmaceuticals intended to be used in an emergency for the rapid, initial treatment of an injury. It is typically used by emergency medical services (EMS), hospitals, institutions, schools, and other public settings. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRR	First Aid Kit With Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 96f40a28-5fe5-4b5f-8acc-69d9d8f3f024
Public Version Date: February 01, 2024
Public Version Number: 1
DI Record Publish Date: January 24, 2024